Deciphering B and T cell Co-stimulation for the Targeted Treatment of IgG4-Related Disease - GR-2021-12372898

OSPEDALE SAN RAFFAELE0 个研究点目标入组 32 人开始时间: 2023年2月8日最近更新: 2023年9月11日

适应症

试验速览

暂无简介。

•1. Male or female subjects of legal age and able to provide informed consent
•2. Patients with active IgG4-related disease naive to therapy or relapsing with an IgG4-RD RI > 2
•3. Achievement of the 2019 ACR/EULAR Classification Criteria of IgG4-related disease.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•- Malignancy within 5 years
•- Chronic or history of recurrent infections over 6 months prior to screening
•- Evidence of severe active liver disease unrelated to IgG4RD
•- Concomitant uncontrolled disease that would interfere with the study procedures
•- Positive HIV, HBV, HCV serology
•- Positive quantiferon test
•- Inability to be tapered of glucocorticoid therapy by 8 weeks post randomisation
•- Prior use of B cell depleting agents within 6 months of enrolment
•- Leukopenia, neutropenia, thrombocytopenia, or anemia
•- Serum creatinine > 2.0 mg/dL at the time of randomisation.
•- Positive pregnancy test at screening or during the study, or breast feeding
•- Subjects who do not agree to use methods of contraception.

发起方

OSPEDALE SAN RAFFAELE